Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent…
Read the official notice →- Date
- 2025-01-22
- Country
- United States
- Brand
- Accriva Diagnostics
- Product
- VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Classification
- Class II
- Units
- US Nationwide distribution in the state of VA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Accriva Diagnostics recalls
- 2026-06-24
USAccriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Assayed Whole blood control contains labeling with incorrect performance range.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-12-10
- US
Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood…
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of OH, IL, NY,…Official notice → - 2025-11-19
- US
Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in…
Due to an device without a premarket clearance being incorrectly package and distributed.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL,…Official notice → - 2024-11-06
- US
Accriva Diagnostics, Inc. recalls AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to…
- 2022-06-01
- US
Accriva Diagnostics, Inc. recalls The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12…
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays…
FDA · DeviceAccriva Diagnostics, Inc.US Nationwide distribution in the state of California.Official notice →
Other drugs & medical recalls in the United States
- 2025-01-29
- US
First Aid Beauty Ltd recalls First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD,…
CGMP Deviations; product intended for quarantine was inadvertently distributed
- US
Brands International Corporation recalls Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X…
CGMP Deviations: lack of adequate release testing.
- 2025-01-22
- US
Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used…
Potential for distal tip tearing of the Mechanical Lithotriptor V.
- US
A L I Technologies Ltd recalls Change Healthcare Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
FDA · DeviceA L I Technologies LtdUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…
FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, LA and the country…Official notice → - US
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of IN, TN & TX.Official notice →